At a glance
ClinicalIndex Comparison Record- ✓Early occlusal carious lesions without cavity on permanent molar 6 or 7 at eruption, not requiring invasive treatment
- ✓Age 5 years or older
- ✓Lesions must be fully visible, assessable, and accessible
- ✓Willing and able to attend study visits and maintain good oral hygiene
- ✕Evidence of tooth erosion
- ✕Fluoride varnish application within 3 months prior to study treatment
- ✕History of head and neck cancer or related illnesses
- ✕Pathology or concomitant medication affecting salivary flow or causing dry mouth
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised Study
In Brief
A Phase 2 clinical trial evaluating self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®) for Dental Caries. Completed, enrolled 70 participants.
Detailed Summary
Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions. Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups.
Study Details
Timeline
Interventions
Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions
Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions